Safety analysis of Oseltamivir and Baloxavir Marboxil after market approval: a pharmacovigilance study based on the FDA adverse event reporting system.

BACKGROUND AND OBJECTIVES: Amidst limited influenza treatment options, evaluating the safety of Oseltamivir and Baloxavir Marboxil is crucial, particularly given their comparable efficacy. This study investigates post-market safety profiles, exploring adverse events (AEs) and their drug associations to provide essential clinical references. METHODS: A meticulous analysis of FDA Adverse Event Reporting System (FAERS) data spanning the first quarter of 2004 to the fourth quarter of 2022 was conducted. Using data mining techniques like reporting odds ratio (ROR), proportional reporting ratio, Bayesian Confidence Propagation Neural Network, and Multiple Gamma Poisson Shrinkage, AEs related to Oseltamivir and Baloxavir Marboxil were examined. Venn analysis compared and selected specific AEs associated with each drug. RESULTS: Incorporating 15,104 Oseltamivir cases and 1,594 Baloxavir Marboxil cases, Wain analysis unveiled 21 common AEs across neurological, psychiatric, gastrointestinal, dermatological, respiratory, and infectious domains. Oseltamivir exhibited 221 significantly specific AEs, including appendicolith [ROR (95% CI), 459.53 (340.88 ∼ 619.47)], acne infantile [ROR (95% CI, 368.65 (118.89 ∼ 1143.09)], acute macular neuroretinopathy [ROR (95% CI), 294.92 (97.88 ∼ 888.64)], proctitis [ROR (95% CI), 245.74 (101.47 ∼ 595.31)], and Purpura senile [ROR (95% CI), 154.02 (81.96 ∼ 289.43)]. designated adverse events (DMEs) associated with Oseltamivir included fulminant hepatitis [ROR (95% CI), 12.12 (8.30-17.72), n=27], ventricular fibrillation [ROR (95% CI), 7.68 (6.01-9.83), n=64], toxic epidermal necrolysis [ROR (95% CI), 7.21 (5.74-9.05), n=75]. Baloxavir Marboxil exhibited 34 specific AEs, including Melaena [ROR (95% CI), 21.34 (14.15-32.18), n = 23], cystitis haemorrhagic [ROR (95% CI), 20.22 (7.57-54.00), n = 4], ileus paralytic [ROR (95% CI), 18.57 (5.98-57.71), n = 3], and haemorrhagic diathesis [ROR (95% CI), 16.86 (5.43-52.40)), n = 3]. DMEs associated with Baloxavir Marboxil included rhabdomyolysis [ROR (95% CI), 15.50 (10.53 ∼ 22.80), n = 26]. CONCLUSION: Monitoring fulminant hepatitis during Oseltamivir treatment, especially in patients with liver-related diseases, is crucial. Oseltamivir's potential to induce abnormal behavior, especially in adolescents, necessitates special attention. Baloxavir Marboxil, with lower hepatic toxicity, emerges as a potential alternative for patients with liver diseases. During Baloxavir Marboxil treatment, focused attention on the occurrence of rhabdomyolysis is advised, necessitating timely monitoring of relevant indicators for those with clinical manifestations. The comprehensive data aims to provide valuable insights for clinicians and healthcare practitioners, facilitating an understanding of the safety profiles of these influenza treatments in real-world scenarios.

Stability between single and segmental maxillary osteotomies in bimaxillary surgery for cleft-associated class III deformity: a CBCT study.

OBJECTIVE: Segmental Le Fort I osteotomy through the cleft is a common strategy to narrow the alveolar cleft in adults. This study compared skeletal stability between single and segmental Le Fort I osteotomies in patients with unilateral cleft lip and palate (UCLP). MATERIALS AND METHODS: This retrospective analysis examined 45 adults with complete UCLP-associated class III deformities who underwent bimaxillary surgery with either single (n = 30) or segmental (n = 15) Le Fort I advancement. Cone beam computed tomography (CBCT) scans of the facial skeleton were acquired before surgery, 1-week postsurgery, and at follow-up. Measures of landmarks from the CBCT images for the two treatment groups were compared for translation (left/right, posterior/anterior, superior/inferior) and rotation (yaw, roll, pitch). RESULTS: Postsurgery, the downward movement of the maxilla was larger in the segmental group than the single group. At follow-up, the maxilla moved backward in both groups, and upward in the segmental group. The mandible moved forward and upward and rotated upward in both groups. The amount of upward movement and rotation was larger in the segmental group than the single group. CONCLUSIONS: Two years after bimaxillary surgery in patients with UCLP-associated class III deformity, greater relapse was found after segmental Le Fort I osteotomies in vertical translation of the maxilla and mandible, and pitch rotation of the mandible compared with single Le Fort I osteotomies. CLINICAL RELEVANCE: The vertical relapse of the maxilla was larger after segmental Le Fort I advancement compared with single Le Fort I advancement in clefts.

Site and severity of facial asymmetry after bimaxillary surgery for class III deformity: a case-control study.

OBJECTIVES: The study aimed (1) to evaluate the site and severity of facial asymmetry in Class III patients before and after bimaxillary surgery, and (2) to identify the influence of initial severity and positional jaw asymmetry on residual facial asymmetry. MATERIALS AND METHODS: Preoperative and postoperative cone-beam computed tomography of 65 patients with Class III facial asymmetry who underwent bimaxillary surgery were evaluated. Five midline and 14 paramedian facial soft tissue landmarks were identified to assess facial asymmetry. The outcomes were compared to a control group consisting of 30 age- and gender-matched Class I subjects. The postoperative positional jaw asymmetry (i.e., shift, roll, yaw) of each osteotomy segment (maxilla, mandible, chin, ramus) was also measured. RESULTS: Before surgery, the asymmetry was more severe at the chin, middle and lower contour. Bimaxillary surgery effectively corrected facial asymmetry, particularly in achieving normalization of chin deviation. However, significant asymmetry persisted postoperatively in the middle and lower contour (p < 0.001 and p < 0.01, respectively), which was affected by the positional ramus asymmetry in the roll and shift. CONCLUSIONS: Deviation of the chin, middle and lower contour contributed significantly to overall facial asymmetry in Class III asymmetry. Despite normalization of the chin deviation after bimaxillary surgery, asymmetry persisted at the middle and lower contour, primarily as the result of insufficient correction of the positional ramus asymmetry. CLINICAL RELEVANCE: Understanding the residual asymmetry after bimaxillary surgery is important for minimizing deviation and optimizing the surgical planning for its correction.

Three-dimensional evaluation of skeletal stability after surgery-first bimaxillary surgery for class III asymmetry in 70 consecutive patients.

Background/purpose: Skeletal stability after orthognathic surgery is essential for positive treatment outcome. This study evaluated the stability of osteotomy segments after surgery-first bimaxillary surgery for class III asymmetry. Materials and methods: Seventy adults with class III asymmetry consecutively corrected through surgery-first Le Fort I and bilateral sagittal split osteotomies were investigated. Cone-beam computed tomography before treatment (T0), 1-week after surgery (T1), and after all treatment (T2, ≥1-year after surgery) was used to assess surgical movement (T0 to T1) and skeletal stability (T1 to T2) regarding the translation and rotation of the maxillary, mandibular distal, and proximal segments. Results: At T1, the maxillary segment had moved forward and upward, turned to the deviated side, and rotated downward (all P < 0.01). The distal segment of mandible had moved forward and upward and rotated upward (all P < 0.001). The deviated proximal segment had moved upward, tilted to the opposite side, and rotated upward (all P < 0.001). The opposite proximal segment had moved upward and tilted to the deviated side (both P < 0.01). At T2, significant relapse occurred in the mandible. The distal segment moved forward and upward and rotated upward (all P < 0.001). The deviated proximal segment moved upward, tilted to the opposite side, and rotated upward (all P < 0.001). The opposite proximal segment moved upward and tilted to the deviated side (both P < 0.01). Conclusion: Clinically significant relapse of class III asymmetry was discovered on the mandibular distal and opposite proximal segments.

Three-dimensional positioning of the maxilla using novel intermediate splints in maxilla-first orthognathic surgery for correction of skeletal class III deformity.

OBJECTIVES: Successful orthognathic surgery requires accurate transfer of the intraoperative surgical plan. This study aimed to (1) evaluate the surgical error of a novel intermediate splint in positioning the maxilla during maxilla-first orthognathic surgery and (2) determine factors influencing surgical error. MATERIALS AND METHODS: This prospective study examined 83 patients who consecutively underwent Le Fort I osteotomy for correction of skeletal class III deformity using a novel intermediate splint and a bilateral sagittal split osteotomy. Surgical error was the outcome variable, measured as the difference in postoperative translational and rotational maxillary position from the virtual plan. Measures included asymmetry, need and amount for mandibular opening during fabrication of intermediate splints, and planned and achieved skeletal movement. RESULTS: Mean errors in translation for vertical, sagittal, and transversal dimensions were 1.0 ± 0.7 mm, 1.0 ± 0.6 mm, and 0.7 ± 0.6 mm, respectively; degrees in rotation for yaw, roll, and pitch were 0.8 ± 0.6, 0.6 ± 0.4, and 1.6 ± 1.1, respectively. The transverse error was smaller than sagittal and vertical errors; error for pitch was larger than roll and yaw (both p < 0.001). Error for sagittal, transverse, and roll positioning was affected by the achieved skeletal movement (roll, p < 0.05; pitch and yaw, p < 0.001). Surgical error of pitch positioning was affected by planned and achieved skeletal movement (both p < 0.001). CONCLUSIONS: Using the novel intermediate splint when performing Le Fort I osteotomy allowed for accurate positioning of the maxilla. CLINICAL RELEVANCE: The novel intermediate splint for maxillary positioning can be reliably used in clinical routines.

Surgery-First Orthognathic Approach for Correction of Dentofacial Deformity in Unilateral Cleft Lip and Palate.

BACKGROUND: Although several studies have reported the advantages of the surgery-first approach for orthognathic correction of class III deformity, there is no report of the success of this approach for patients with cleft lip and palate. Therefore, the purpose of this study was to evaluate the stability and outcome of bimaxillary surgery for cleft-related dentofacial deformity using a surgery-first approach. METHODS: Forty-one patients with unilateral cleft lip and palate who consecutively underwent Le Fort I and bilateral sagittal split osteotomies for skeletal class III deformity were included. Cone-beam computed tomographic scans before surgery, 1 week after surgery, and after orthodontic treatment were used to measure the surgical and postsurgical changes in jaw position by landmarks, and outcomes of jaw protrusion and relation, incisor angle and occlusion, and menton deviation after treatment. Self-report questionnaires regarding satisfaction with overall appearance of the face and seven facial regions were administered after treatment. RESULTS: A clinically insignificant relapse was found in the maxilla (<1 mm) and mandible (<2 mm). There was a significant improvement in the jaw protrusion and relation, incisor angle and occlusion, and menton deviation. Responses from the self-report questionnaires completed after treatment indicated that patient satisfaction was high. CONCLUSION: These findings demonstrate surgical-orthodontic treatment with a surgery-first approach can successfully improve cleft-related dentofacial deformity in patients with unilateral cleft lip and palate. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

The Impact of Hippocampal-Sparing Whole-Brain Radiotherapy on Survival and Cognitive Function in Patients with Brain Metastases.

Objective: To explore the effects on cognitive function and survival time of whole-brain intensity-modulated radiotherapy using radiotherapy equipment to protect the hippocampus. Methods: Thirty-six patients with brain metastases treated at Qianjiang Central Hospital were enrolled in this study from January 2019 to September 2022. The patients were randomly divided into 2 groups: 15 patients received hippocampal-protection whole-brain radiotherapy, and 21 patients received conventional whole-brain radiotherapy. The Montreal Cognitive Assessment was used to evaluate the cognitive function of patients before and 24 hours, 2 months, 6 months, and 12 months after radiotherapy. Cognitive dysfunction and survival time were compared between the 2 groups. Results: The overall mean differences in the Montreal Cognitive Assessment scores between the hippocampal-protection group and the conventional whole-brain radiotherapy group were statistically significant at 6 months (P = .006) and 12 months (P = .04) after radiotherapy. The median overall survival was 16 months (95% CI, 11.54-20.46) for the hippocampal-protection group and 14 months (95% CI, 12.9-15.21) for the conventional whole-brain radiotherapy group (P = .578). The median progression-free survival was 12 months (95% CI, 9.74-14.26) for the hippocampal-protection group and 9 months (95% CI, 6.60-11.44) for the conventional whole-brain radiotherapy group (P = .494). Conclusion: Whole-brain radiotherapy for protecting the hippocampus can delay cognitive dysfunction in patients to some extent.

Assessing safety concerns of interstitial lung disease associated with antibody-drug conjugates: a real-world pharmacovigilance evaluation of the FDA adverse event reporting system.

BACKGROUND: Antibody-drug conjugates have revolutionized cancer therapy due to their selectivity and efficacy. However, concerns have been raised regarding the potential effects of trastuzumab deruxtecan in interstitial lung diseases. AIM: This study aimed to investigate the safety signals and time to onset of antibody-drug conjugates induced interstitial lung disease. METHOD: We utilized the FDA Adverse Event Reporting System database (2004-2022) to identify interstitial lung disease safety signals in 13 FDA-approved antibody-drug conjugates. Disproportionality analysis was conducted to estimate the reporting odds ratios for interstitial lung disease. RESULTS: Seven antibody-drug conjugates exhibited safety signals of interstitial lung disease: trastuzumab deruxtecan [reporting odds ratio, ROR (95% confidence intervals, CI) = 64.15 (57.07-72.10)], enfortumab vedotin [ROR (95% CI) = 5.24 (3.25-8.43)], trastuzumab emtansine [ROR (95% CI) = 3.62 (2.90-4.53)], brentuximab vedotin [ROR (95% CI) = 3.22 (2.49-4.17)], polatuzumab vedotin [ROR (95% CI) = 2.56 (1.59-4.12)], gemtuzumab ozogamicin [ROR (95% CI) = 2.53 (1.70-3.78)], and inotuzumab ozogamicin [ROR (95% CI) = 2.33 (1.21-4.49)]. Five antibody-drug conjugates with limited reports were excluded from further analysis: belantamab mafodotin, loncastuximab tesirine, mirvetuximab sorafenib, tisotumab vedotin, and moxetumomab pasudotox. Japan and the United States were the primary reporting countries. CONCLUSION: This real-world study highlights high safety signals of interstitial lung disease associated with antibody-drug conjugates. Clinicians should be aware of these safety concerns and risk factors and implement early identification measures for their patients. Future research should prioritize comprehensively exploring the relationship between antibody-drug conjugates and lung diseases.

Lip and tongue strength associated with chewing patterns in aging population.

BACKGROUND: Improving chewing function of older adults increases the health-related quality of life. Few studies indicated the correlation between tongue, lip strength on masticatory performance in older people. The study aimed to investigate the association between lip, tongue strength on chewing pattern in aging population. METHODS: The older adults had independent daily intake without assistance were enrolled. They had intact dentition and no periodontitis. To estimate the number of chewing strokes and chewing time by consuming a cornstarch cookie were used to represent chewing pattern. Lip and tongue pressure were evaluated with an Iowa Oral Performance Instrument. Linear regression analysis was used to analyze the lip and tongue pressure associated with the chewing time and strokes. Spearman's correlation analysis was utilized to evaluate the associations among chewing time and chewing strokes or lip and tongue pressure. RESULTS: 35 women and 35 men with an average age of 73.2 years were investigated. Tongue pressure was significantly related to the chewing time and the number of chewing strokes (p = 0.01 and 0.03). There was a close association between chewing time and the number of chewing strokes (p < 0.0001). The correlation between lip and tongue pressure was significant (p < 0.0001). CONCLUSION: The tongue strength significantly related to chewing ability in aging population. Increasing the tongue strength greatly reduced the number of chewing strokes and chewing time. Good masticatory ability could increase the motor function of tongue; raising the tongue strength might be able to improve mastication in older adults.

Surgical occlusion setup and skeletal stability of correcting cleft-associated class III deformity using surgery-first bimaxillary surgery.

BACKGROUND: This study aimed to assess the three-dimensional (3D) quantitative characteristics of the surgical occlusion setup in surgery-first cleft orthognathic surgery, and to evaluate its influence on post-surgical skeletal stability. METHODS: This prospective study was comprised of 35 patients with unilateral cleft lip and palate and class III deformity who consecutively underwent two-jaw surgery with surgery-first approach. Digitized dental models were analyzed to quantify the 3D characteristics of the final surgical occlusion setup. Cone-beam computed tomography was used to measure the 3D surgical skeletal movement and post-surgical skeletal stability. The correlation between skeletal stability and surgical occlusal contact or surgical skeletal movement was also evaluated. RESULTS: The surgical occlusion setup had a large incisor overjet and positive overbite, and buccal cross bite and open bite on second molars. Occlusal contact on three segments was present in 51.4% of the patients, and the average number for tooth contact was 4.3 teeth. No correlation was found between maxillary or mandibular stability and surgical occlusal contact. However, a significant correlation was found between maxillary and mandibular stability and the surgical skeletal movement. CONCLUSIONS: The surgical occlusion for correction of cleft-associated class III deformity using the surgery-first approach was characterized with large overjet and positive overbite, and posterior cross bite and open bite. On average, there was occlusal contact on four to five teeth; half of surgical occlusion setups had contact on three segments. The post-surgical skeletal stability was not related to the surgical occlusal contact but to the surgical skeletal movement.

Outcomes of alveolar cleft repair in complete cleft lip and palate after tertiary gingivoperiosteoplasty and segmental Le Fort I osteotomy.

OBJECTIVES: Gingivoperiosteoplasty is often used for reconstruction of alveolar defects in infants with cleft lip and palate. This study aimed to examine outcomes of tertiary gingivoperiosteoplasty, which has not previously been investigated. MATERIALS AND METHODS: This prospective study included 11 adults with complete cleft lip and palate (n = 12 sites) who consecutively underwent segmental Le Fort I osteotomy and concomitant gingivoperiosteoplasty for correction of skeletal class III deformity, nasoalveolar fistula and alveolar cleft. Outcomes included clinical and radiographic evaluations of gingivoperiosteoplasty at the time of osteotomy (presence of nasoalveolar fistula, residual cleft defect and unsupported root ratio of cleft-adjacent teeth), and determination of influencing factors for the clinical success of alveolar cleft repair. Study variables included age, gender, pre-surgical orthodontic treatment and alveolar cleft width of cleft-adjacent canine and angulation between cleft-adjacent teeth before surgery and 1-week postsurgery. RESULTS: Posttreatment, no nasoalveolar fistula remained. The residual cleft defect decreased significantly (p < 0.01). The unsupported root ratio of cleft-adjacent teeth did not differ (p > 0.05); eight cleft sites reached Bergland I or II (67% success). One-week postsurgery, the minimal alveolar cleft width of cleft-adjacent canine was significantly less in the success group compared with the failed group (p = 0.01). CONCLUSIONS: Tertiary gingivoperiosteoplasty and segmental Le Fort I osteotomy decreased nasoalveolar fistulas and induced alveolar bone formation. The minimal alveolar cleft width immediately after surgery was the major influencing factor of clinical success. CLINICAL RELEVANCE: Segmental Le Fort I osteotomy with simultaneous gingivoperiosteoplasty efficaciously repairs adult alveolar clefts.

Post-marketing safety concerns with nirmatrelvir: A disproportionality analysis of spontaneous reports submitted to the FDA Adverse Event Reporting System.

AIMS: Nirmatrelvir is an antiviral drug with a novel mechanism of action, targeting the 3-CL protease, and is used in the treatment of COVID-19. However, the potential side effects have not yet been fully studied. The aim of this study was to identify potential safety signals of nirmatrelvir by analysing post-marketing safety data based on the largest publicly available worldwide pharmacovigilance database. METHODS: We analysed nirmatrelvir adverse events to identify and characterize relevant safety signals based on the FDA Adverse Event Reporting System database in 2022. The case/non-case approach was used to estimate the reporting odds ratio (ROR) and information component (IC) with relevant confidence intervals (95% CI) for adverse events (AEs) that numbered 4 or more. RESULTS: A total of 26 846 cases were included. Disease recurrence (ROR [95% CI] = 413.2 [395.6-431.59]), dysgeusia (ROR [95% CI] = 110.84 [106.04-115.85]), anosmia (ROR [95% CI] = 15.21 [12.76-18.11]), ageusia (ROR [95% CI] = 9.80 [8.50-11.3]) and urticaria (ROR [95% CI] = 1.91 [1.69-2.17]) were the main safety signals. In addition, abdominal pain upper and skin toxicity were two specific safety signals of nirmatrelvir. In the pregnant population, there was a significant increased ROR for life-threatening conditions (ROR [95% CI] = 8.00 [1.77-36.20]). CONCLUSIONS: Our study identified that the main and specific safety signals of nirmatrelvir were disease recurrence, dysgeusia, abdominal pain upper and skin toxicity. Clinicians and pharmacists should be vigilant of these AEs, although differentiating between COVID-19 symptoms and AEs can be challenging. Notably, a potential safety concern of nirmatrelvir should be a warning based on a small number of events in the pregnant population. However, the available data are insufficient, and further continued pharmacovigilance and surveillance is needed to fully understand this issue.

Comparison of Facial Growth between Two Nasoalveolar Molding Techniques in Patients with Unilateral Complete Cleft Lip.

BACKGROUND: Nasoalveolar molding (NAM) has become standard treatment in the authors' craniofacial center. There are two types of presurgical NAM: the Grayson and Figueroa techniques. The Grayson method involves active alveolar molding, and the Figueroa method involves passive alveolar molding. The authors previously found no differences in number of clinic visits, costs, or 6-month postoperative outcome between the two techniques. The authors extended the previous study to evaluate facial growth between these two groups. METHODS: In this randomized single-blind study, conducted between May of 2010 and March of 2013, the authors recruited 30 patients with unilateral complete cleft lip and palate and randomized them for Grayson or Figueroa presurgical NAM. Standard lateral cephalometric measurements at 5 years were used to determine facial growth. RESULTS: Twenty-nine patients completed 5 years of follow-up. There were no statistically significant differences in facial cephalometric measurements between the two groups. CONCLUSION: Presurgical NAM using either a passive or active NAM technique produced similar facial growth patterns after unilateral cleft lip and palate repair. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Comparison of regional soft tissue changes after bimaxillary rotational surgery between class III deformity with overbite and open bite: A 3D imaging analysis.

BACKGROUND: This prospective study aimed to compare regional soft tissue changes between patients with class III overbite and open bite deformities treated with bimaxillary surgery involving clockwise and counter-clockwise mandibular setback, respectively. MATERIAL AND METHODS: Class III deformity adults receiving Le Fort I and bilateral sagittal split osteotomies were grouped according to the incisal occlusion: overbite (n = 30) and open bite (n = 30). Combined cone-beam CT scans and 3D facial photographs preoperative and at least 1-year postoperative were taken to assess the soft tissue changes. RESULTS: Postoperative changes for the overbite and open bite groups included anterior repositioning of nose (-0.8 ± 1.2 mm and -1.1 ± 1.1 mm, respectively) and cheek (-1.9 ± 1.3 mm and -1.7 ± 2.6 mm, respectively), posterior repositioning of chin (5.2 ± 4.0 mm and 4.9 ± 3.2 mm, respectively), and medial (-1.7 ± 2.0 mm and -1.9 ± 2.1 mm, respectively) and posterior (2.7 ± 1.4 mm and 2.8 ± 2.3 mm, respectively) repositioning of bilateral angles. Posterior (1.2 ± 2.0 mm and 5.1 ± 3.3 mm) and inferior (-1.4 ± 2.2 mm and -2.4 ± 2.7 mm) repositioning of upper lip and lower lip occurred in overbite group. Inferior (-2.3 ± 2.4 mm) and superior (3.7 ± 3.4 mm) repositioning of chin occurred in the overbite and open bite groups, respectively. CONCLUSIONS: Treatment of class III overbite and open bite deformities with bimaxillary rotational surgery resulted in comparable regional soft tissue changes, except for upper lip, lower lip and chin.

The correlation between two occlusal analyzers for the measurement of bite force.

BACKGROUND: Occlusal force represents masticatory function. Using quantifiable occlusal indicators provides a more objective occlusal force evaluation. In the recent dental practice, digital methods such as the Dental Prescale II (DP2, GC Corp., Tokyo, Japan) and T-scan (T-Scan III v8; Tekscan Inc.) are commonly used in clinics to evaluate treatment outcomes. The T-scan provides the relative bite force (%) compared to the maximal bite force on individual teeth or the unilateral arch. The DP2 can quantify occlusal force, measured in newtons (N), on the half arch or the overall bite, but it is difficult to identify the bite force on an individual tooth. It is difficult to select a device that fulfils all the requirements to record occlusal force. This study aimed to investigate the association between the bite measured by the DPS2 and T-scan to determine whether the measured bite force is comparable through calculation. METHODS: A total of 80 healthy adults, including 41 women and 39 men with a mean age of 38.2, were requested to bite pressure sensitive film sheets ten minutes apart. Linear regression analysis was used to estimate the measured bite force by the DP2 and T-scan. RESULTS: There was a significant positive correlation between the occlusal force measured by the DP2 and T-scan (P < 0.01) when intercept was equal to zero as confounders were adjused. These results provided the comparability of the measured occlusal forces determined by the DP2 and T-scan. CONCLUSION: The estimated bite force determined by DP2 and T-Scan is convertible using the linear equation from this study to increase the value for clinical applications. The estimated bite force from the two quantifiable occlusal indicators are comparable. The two commercially available quantifiable occlusal indicators can be fully adapted to all clinical requirements according to this result.

The impact of dental therapy timelines and irradiation dosages on osteoradionecrosis in oral cancer patients: A population-based cohort study.

OBJECTIVES: This study aimed to investigate how different timelines of various dental therapies were related to osteoradionecrosis development under consideration of radiotherapy dosage in patients with oral cancer. MATERIALS AND METHODS: A total of 7,107 oral cancer patients were enrolled, including 88 osteoradionecrosis patients treated with low radiotherapy dosages (<60 Gy) or high radiotherapy dosages (≥60 Gy), from the Longitudinal Health Insurance Database for Catastrophic Illness Patients of Taiwan. Cox proportional hazard regression was used to compare the osteoradionecrosis risk of various dental treatment timelines under different irradiation dosages. RESULTS: In the oral cancer population with low irradiation dosages (<60 Gy), performing periodontal therapy combined with irradiation significantly raised the risk of osteoradionecrosis by 2.21-fold. Starting radiotherapy within three months after dental surgery greatly increased the risk of developing osteoradionecrosis by 1.87-fold. The oral cancer patients treated with high radiation doses (≥60 Gy) receiving dental surgery within one month prior to radiotherapy had a significantly raised osteoradionecrosis occurrence by 1.60-fold. While the dental surgery was performed during the radiotherapy course, the risk of osteoradionecrosis was greatly increased by 2.21-fold. CONCLUSION: For oral cancer patients, performing dental surgery within three months before radiotherapy might significantly induce osteoradionecrosis. Patients that were treated with high irradiation dosages (≥60 Gy) had a higher tendency to develop osteoradionecrosis if they received dental surgery during radiotherapy. Those who were treated with low radiation dosages (<60 Gy) and received periodontal therapy during radiotherapy might have an increased risk in developing osteoradionecrosis.

Skeletal stability after bimaxillary surgery with surgery-first approach for class III asymmetry is not related to virtual surgical occlusal contact.

OBJECTIVES: Surgery-first orthognathic surgery is rarely used in class III asymmetry due to concerns of reduced skeletal stability from unstable surgical occlusion. This study aimed to evaluate if skeletal stability after surgery-first orthognathic surgery is related to virtual surgical occlusal contact or surgical change. MATERIALS AND METHODS: We studied 58 adults with class III asymmetry, consecutively corrected by Le Fort I osteotomy and bilateral sagittal split osteotomy using a surgery-first approach. Dental casts were manually set to measure virtual surgical occlusal contact including contact distribution, contact number, and contact area. Cone-beam computed tomography taken before treatment, 1-week post-surgery, and after treatment was used to measure surgical change and post-surgical stability of the maxilla and mandible in translation (left/right, posterior/anterior, superior/inferior) and rotation (pitch, roll, yaw). The relationship between skeletal stability and surgical occlusal contact or surgical change was evaluated with correlation analysis. RESULTS: Significant instability was found in the mandible but not in the maxilla. No correlation was found between the maxillary or mandibular stability and surgical occlusal contact (all p > 0.01). However, a significant correlation was found between the maxillary (roll and yaw) or mandibular (shift, roll and pitch) stability and its surgical change (all p < 0.001). CONCLUSIONS: In correction of class III asymmetry with surgery-first bimaxillary surgery, the skeletal stability is not related to the virtual surgical occlusal contact, but surgical skeletal change. CLINICAL RELEVANCE: Planned over-correction is a reasonable option for correction of severe shift or roll mandibular asymmetry in bimaxillary surgery for class III deformity.

Is the pattern of mandibular asymmetry in mild craniofacial microsomia comparable to non-syndromic class II asymmetry?

OBJECTIVES: To compare the characteristics of mandibular asymmetry in patients with unilateral craniofacial microsomia (CFM) and class II asymmetry. MATERIALS AND METHODS: Pretreatment cone-beam computed tomography of consecutive adults with Pruzansky-Kaban type I and IIA CFM (CFM group) was analyzed by 3D cephalometry. Fourteen mandibular landmarks and two dental landmarks were identified. The mandibular size and positional asymmetry were calculated by using landmark-based linear and volumetric measurements, in terms of asymmetry ratios (affected/non-affected side) and absolute differences (affected - non-affected side). Results were compared with non-syndromic class II with matched severity of chin deviation (Class II group). Statistical analyses included independent t test, paired t test, chi-square test, and ANOVA. RESULTS: CFM group (n, 21; mean age, 20.4 ± 2.5 years) showed significantly larger size asymmetry in regions of mandibular body, ramus, and condyle compared to Class II group (n, 21; mean age, 27.8 ± 5.9 years) (p < 0.05). The curvature of mandibular body was asymmetric in CFM. Regarding the positional asymmetry of mandibular body, while a comparable transverse shift and a negligible yaw rotation were found among the two groups, the roll rotation in CFM was significantly greater as well as the occlusal (6.06° vs. 4.17°) and mandibular (7.84° vs. 2.80°) plane cants (p < 0.05). CONCLUSIONS: Mild CFM showed significantly more severe size asymmetry and roll rotation in mandible than non-CFM class II asymmetry. CLINICAL RELEVANCE: To improve the mandibular size and positional asymmetry in CFM, adjunct hard tissue augmentation or reduction in addition to OGS orthodontics with a meticulous roll and yaw planning is compulsory, which is expected to be distinct from treating non-CFM class II asymmetry.

Off-label indications of aspirin in gynaecology and obstetrics outpatients at two Chinese tertiary care hospitals: a retrospective cross-sectional study.

OBJECTIVE: To investigate the prevalence of off-label aspirin indications and the level of scientific support for off-label indications of aspirin in gynaecology and obstetrics outpatients. DESIGN: A retrospective cross-sectional study. SETTING: Two tertiary hospitals (a general hospital and a women and children's specialised hospital) in Xiamen, a city located on the southeastern coast of China. PARTICIPANTS: A total of 4257 prescriptions were included for 2091 female patients aged >18 who visited the gynaecology and obstetrics outpatient clinics and received aspirin treatment. OUTCOME MEASURES: The primary measure of this study was the proportion of off-label indications and of off-label indications supported by strong scientific evidence. Evidence from clinical guidelines and Micromedex is shown using descriptive statements. On-label indications of drugs in the same class as aspirin were also referred to for off-label aspirin use without strong evidence support. RESULTS: All indications of aspirin on outpatient prescriptions were determined as off-label use in this study. The most frequent off-label indication was recurrent miscarriage (2244 prescriptions, 52.71%). Totally, 30.94% of the prescriptions were supported by strong evidence for indications, including recurrent miscarriage with antiphospholipid syndrome and prophylaxis for pre-eclampsia. No drugs in the same class as aspirin had on-label indications for off-label aspirin use without strong evidence support. CONCLUSIONS: This study demonstrated that all indications of aspirin used in gynaecology and obstetrics outpatients at the two tertiary hospitals were off-label and not always supported by strong evidence, implicating that physicians should be cautious when issuing off-label prescriptions. More original clinical research on off-label aspirin use is needed to provide reference for routine clinical practice.